Spray foam splint

ABSTRACT

Orthopedic splinting materials and methods for stabilizing an injured limb or extremity of a human or animal comprising applying a foam to the limb or extremity and allowing the foam set to sufficient rigidity, which can be in less than 60 seconds. The foam, such as a Spray Polyurethane Foam, can be sprayed directly on the skin without producing an amount of heat release that is painful or uncomfortable on the skin. Also provided is a kit for stabilizing an injured limb or extremity comprising a dispenser comprising the present foam. Further provided is situ preparation and application of a compression bandage on an injured patient in an emergency or combat situation comprising applying the present foam. A spine board and a method for making the same comprising applying the present foam to the patient&#39;s back, then contacting the foam with a board or flat surface before the foam sets.

FEDERALLY-SPONSORED RESEARCH AND DEVELOPMENT

This invention is assigned to the United States Government. Licensinginquiries may be directed to Intellectual Property Office, USAMRMC, 504Scott Street, Fort Detrick, Md., 21702-5012. Tel: (301)619-7808. Fax:(301)619-5034. E-mail: Elizabeth.Arwine@amedd.army.mil. Reference ArmyCase No. WBAMC 09-25.

BACKGROUND

This is a National Phase Application filed under 35 U.S.C. 371 as anational stage of PCT/US2010/057240, filed Nov. 18, 2010, the content ofwhich is hereby incorporated by reference in its entirety.

This disclosure relates to orthopedic splinting materials and methodsfor using a fast setting rigid spray foam, and may optionally comprisespraying the foam directly onto a fractured extremity without the use ofpre-wraps.

SUMMARY

The present subject matter relates to orthopedic splinting materials andmethods for stabilizing an injured limb or extremity of a human oranimal comprising applying a foam to the limb or extremity and allowingthe foam set to sufficient rigidity. In some embodiments, the foam issprayed directly on the skin and does not produce an amount of heatrelease that is painful or uncomfortable on the skin. In certainembodiments, the foam sets to sufficient rigidity in less than 60seconds. In a specific embodiment, the foam is a Spray Polyurethane Foam(SPF) that sets in less than 60 seconds and does not produce an amountof heat release that is painful or uncomfortable on the skin. Alsoprovided is a one-step method for stabilizing an injured limb orextremity of a patient in an emergency, combat, or pediatric situationcomprising dispensing a foam of the present subject matter directly onthe injured limb or extremity. A kit is also provided for stabilizing aninjured limb or extremity comprising a dispenser comprising a foamablecomposition of the present subject matter. A spine board and a methodfor making the same comprising applying a foam of the present subjectmatter to the back of the patient and then contacting the foam with aboard or flat surface before the foam sets. The present subject matteralso relates to situ preparation and application of a compressionbandage on an injured patient in an emergency or combat situationcomprising applying a rigid foam of the present subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a photograph of an example of a rigid foam cast of thepresent subject matter sprayed directly on the skin of the arm, wrist,and hand. FIG. 1B is a photograph of the cast in FIG. 1A after the armis removed from the cast. This example used the two-componentquick-curing Spray Polyurethane Foam (SPF) sold under the trade nameFROTH-PAK (Dow Chemical Corporation).

FIG. 2 schematically shows one embodiment of a kit of the presentsubject matter comprising a dispenser comprising a foamable compositionof the present subject matter. FIG. 2A shows the assembled kit. FIG. 2Bshows packages of dry antibiotic, dry hemostatic agent, and a medicaldressing for dressing open wounds are provided in this example of thekit, such as being placed under one or more end caps or attached to thecan. Also in this example, a second detachable cap is provided havingone open end and the other end of the cap is open and fitted with adetachable cover.

FIG. 3A (top view) and 3B (side view) schematically show an example of arigid foam cast of the present subject matter on an injured extremityhaving an open wound and comprising an open-ended walled-form with anoptional detachable cover. The walled form is placed over the wound areabefore the rigid foam cast is sprayed on the injured extremity so thatthe wound can remain open to observation or access after the foam castis dispensed to stabilize the injured limb or extremity.

FIG. 4 schematically shows one embodiment of a spine board of thepresent subject matter and a method of preparing and placing the spineboard on the patient.

DETAILED DESCRIPTION

The present subject matter relates to orthopedic splinting materials andmethods for stabilizing an injured limb or extremity of a human oranimal comprising applying a foam to the limb or extremity and allowingthe foam set to sufficient rigidity. The currently known techniques forcasting or splinting a human fracture have not changed much throughoutthe course of time. The mainstay is a large heavy splint made fromeither plaster-of-Paris, fiberglass, or in some new conceptspolyurethane. Some of these materials and techniques have becomecommonplace and remain the standard treatment, but there have been manydisadvantages to using these materials and techniques.

Plaster-of-Paris splints are typically very heavy and bulky for thepatient. They also generally require several steps for application, andare not practical for application in most combat or emergencysituations. The area to be splinted must be wrapped with web roll, whichis simple cotton padding. The web roll is critical to get smooth so asnot to create pressure sores. The plaster is then dipped into water, anessential step to activate the plaster, then the plaster is wrappedaround the area circumferentially. The activated plaster initiates anexothermic chemical reaction, meaning heat is released from the plaster,which must be monitored so as to not burn the patient. As the area isdrying, which takes several minutes, the plaster must be molded toensure it does not simply fall off the extremity. Plaster casts areeasily damaged by water, urine, and feces because the cotton web rollacts as a sponge and absorbs any and all fluids holding them on the skincausing irritation and break down. This damage forces the patient toreturn for another cast and more expense, inconvenience, and discomfort.This is particularly a problem in pediatrics due to patient compliance,and the activities they partake in. These casts are also heavy andbulky, even though they have a very low strength to weight ratio, thusthe weight is not to the patient's benefit. Plaster also has noexpandability, which makes swelling a very dangerous problem for thepatient and a concern for the orthopedic surgeon. Evaluating a patientwith plaster is also difficult because plaster has poor radiolucence,obscuring the surgeon's view of the fracture site. Similarly, if thepatient has other wounds on the injured extremity (such as cuts,sutures, open wounds, etc.) and they are covered by the plaster cast,then these may be obscured or require other special procedures.

Fiberglass splints are used and applied in much the same way as that ofplaster. They require cotton web roll pre-wrap and extreme cautionduring application so as not to create areas of pressure. Fiberglassalso requires water to activate the chemical reaction; this reaction isalso exothermic and must be monitored for burns. Fiberglass is alsoknown for drying with very sharp edges that must be padded andconstantly monitored for skin irritation and break down. Skin break downmay require frequent trips to the clinic for cast adjustment, costingtime and money.

Lastly, these traditional splints are used in the pediatric patientpopulation which has additional concerns and consideration for thepatient and the surgeon. One of the most problematic aspects is gettinga pediatric patient to hold still long enough for the surgeon to applyand mold the cast or splint. This is usually overcome by sedating thepatient, and often this requires a trip to the operating room to provideadequate respiratory and cardiac monitoring. This extra step not onlyputs the child at risk of a reaction to the anesthesia but can also costthousands of dollars. Another common problem with this population issoiling of the cast or splint. For example, a spica cast is placedaround the hips and down each leg, where soiling is common and there isconcern that the cotton web roll under the cast will absorb urine andfeces and hold it on the skin causing skin break down and multiple tripsto the operating room for cast changes. A cast that does not absorbliquids and is easily wiped clean would cut huge amounts of cost andpossible injury to the patient. Another advantage would be a cast thatcures much faster thus lessening the time of anesthesia.

The casting and splinting techniques described thus far are most oftenused in a clinic setting and not an acute or emergency situation. Themodern paramedic has very few options when treating a fracture in thefield, due to the portability, size and time most casting techniquesrequire. One such technique is inflatable splints made of plastic; thesedevices are slipped over the extremity and then inflated, thus providingminimal immobilization and forcing the paramedic to move the extremity,and the extremity is forced to take the shape of the air splint. Anothercommon method used is the S.A.M. (Structural Aluminum Malleable) splint.This is a flexible metal covered in foam, which is wrapped around theextremity to provide immobilization. This product also requires theparamedic to move the extremity and wrap it in a circumferential manner,and the splint being made of metal, the mold and conformability islimited often requiring an elastic wrap to be placed around it. Both ofthese methods require the paramedic to manipulate the extremity causingpain, and more importantly possible neurovascular injury. As bonefractures, sharp edges are often produced that if moved can easily cut adelicate nerve or artery causing unnecessary and devastatingcomplications. These techniques also provide very little if any means ofcontrolling bleeding, thus leaving the paramedic to make a decision toeither control bleeding or immobilize the fracture. The ideal splintcould provide both immobilization and hemodynamic control.

Solid foam compositions, including polyurethane foam compositions, havebeen described previously in the medical field for use as implants andpadding. Generally, such foams are inert and do not react withbiological components in the human body and provides little risk ofanaphylaxis. Polyurethane foams have also been previously described foruse in preparing casts or splints. However, all of these methods usepolyurethane in a traditional manner, activating it with water andwrapping the extremity or filling a mold. Generally, the polyurethanefoams described in the cast/splint art produce excessive exothermic heatthat causes patient discomfort, pain, and/or burns on uncovered skin.Also, generally, such polyurethane foams require at least severalminutes before the foam will set to sufficient rigidity required tostabilize the injured extremity or limb. U.S. Pat. No. 4,952,447describes a polyurethane tape-like material that must be activated withwater and then must be wrapped circumferentially over a prewrap. U.S.Pat. No. 4,309,990 describes spraying foam on a bandage strip, applyingan under garment, and wrapping the extremity with the foam bandagestrips over the undergarment. U.S. Pat. No. 6,695,801 describes apolyurethane foam between two layers of material that must expand andform to fit, this takes 12 minutes and has poor surface contact. U.S.Pat. Nos. 2,947,307 and 3,301,252 describe polyurethane foam splintsthat require a cloth prewrap to protect from excessive exothermicreaction heat, also the foams described require several minutes to setto sufficient rigidity.

The foam splints and methods of the present subject matter overcome manyor all of the disadvantages of using previously known foam splintmaterials and methods of applying them.

As used herein the terms “foam” and “rigid foam” refer to athree-dimensional porous material having a reticulated configuration incross section and which is pliable and conformable before it sets, andwhich after it sets is sufficiently rigid to stabilize a broken orinjured limb or extremity of a human or animal. The terms “rigid” or“sufficient rigidity” as used herein refer to a structure that issufficiently rigid to stabilize a broken or injured limb or extremity ofa human or animal. The term “semi-rigid” as used herein refers to a foamthat is substantially rigid or rigid to at least some degree or rigid inat least some parts, and may provide sufficiently rigidity to stabilizea broken or injured limb or extremity of a human or animal in someembodiments. The term “semi-rigid” as used herein also refers to a foama structure that is substantially rigid or rigid to at least some degreeor rigid in at least some parts, and is used as to describe someinsulation foams in the construction trades. In general, foams of thepresent subject matter are quick-setting foams. In some embodiments, thefoams set to sufficient rigidity in less than 5 minutes, such as, forexample, less than 4 minutes, less than 3 minutes, less than 2 minutes,less than 90 seconds, less than 60 seconds, or less than 30 seconds. Theterms “set” and “setting” as used herein refers to the foam achieving asufficient rigidity after the foamable composition is generated and/orapplied.

Quick-setting foams generally undergo an exothermic reaction (release ofheat) during the formation and/or setting of the foam. In some foams ofthe present subject matter, heat is generated for less than 30 secondsas the foam forms and then the generated heat begins dissipating oncethe foam sets. In some embodiments, the temperature generated by thefoam reaches a peak temperature in less than 30 seconds. In oneembodiment, the foam of the present subject matter does not produce anamount of heat release that is uncomfortable, painful, burning, or acombination thereof, including when applied directly on the skin.Polyurethane foams previously used in the art for forming a splint orcast have produced a significant amount of heat release that isuncomfortable, painful, or burning, and requires use of prewraps orother skin-covering to remove or minimize these adverse effects. In oneembodiment, the foam of the present subject matter will generate anamount of heat release that is not uncomfortable, painful, or burningwhen applied directly to skin wherein the average peak temperature ofthe foam measured at the skin is selected from the group consisting of:110° F., less than 110° F., 108° F., less than 108° F., 106° F., lessthan 106° F., 105° F., less than 105° F., 104° F., less than 104° F.,103° F., less than 103° F., 102° F., less than 102° F., 101° F., lessthan 101° F., 100° F., and less than 100° F.

According to one embodiment, the foam of the present subject matter isused as a splinting or casting device for bone fractures, and may beapplied directly on to the skin of the injured extremity creating aperfectly contoured and pressure distributing fixation. Applying a foamof the present subject matter directly on the skin advantageouslyeliminates the need for any and all prewraps, such as circumferentialwraps. Allowing the splint to be applied directly onto the skineliminates the need to use absorbent cotton cast padding that harborsmoisture and bacteria, which commonly occurs with the use ofconventional splints and casts. Therapeutic agents, such as, forexample, antibiotics, analgesics, and/or hemostatic agents, canoptionally be added to the foamable composition, thus adding anotherline of defense to preventing infection, providing comfort, and/orstopping bleeding.

Foams and methods of the present subject matter can be advantageouslyapplied while the wound remains in situ (position of fracture) in thefield even before the patient is extracted from the scene of the injury.Thus, the present subject matter advantageously allows the injury to bestabilized without manipulation, which is a significant improvement uponprior art methods and casts which require the injury to be wrappedcircumferentially with an absorbent dressing and which results in theinjury being subjected to manipulation and movement. Keeping fracturesin their in situ position until the patient is transported to a medicalfacility generally decreases the likelihood of secondary tissueinjuries, bleeding, and infection associated with moving andmanipulating a fractured extremity before the injury is treated.Accordingly, the present subject matter may also reduce multipleexaminations of the open fracture which has been shown to increase therate of infection; the fracture can be left in place until the treatingphysician arrives.

Advantageously, the simplicity of using the methods of the presentsubject matter permit both trained emergency medical personnel andminimally-trained personnel (e.g., non-medical personnel, combatsoldiers, etc.) to successfully practice the methods without significantdifficulty.

In one embodiment, the foams of the present subject matter may provideone or more advantageous features selected from the group consisting of:the foam splint or cast can be applied quickly; the foam splint or castcan be applied with minimal technical training; the foam splint or castcan be applied in the field environment, such as under combat oremergency response conditions; and the foam splint or cast can beapplied on the extremity in its observed position to stabilize it duringextraction. Foams of the present subject matter are generally very lightweight even after it hardens, while its strength is not compromisedcreating a very favorable weight to strength ratio. The load capacity(strength) can be easily manipulated allowing the physician many optionsto meet the needs of a very diverse patient population. In someembodiments, foams of the present subject matter are radiolucent (X-rayscan be taken through it) which allows the surgeon or clinician to easilyassess the bone using radiographs. Additionally, numerous embodiments offoams of the present subject matter are generally impervious to waterand many chemicals, and thus do not absorb urine, sweat, or other bodilyfluids that often contaminate traditional casts. A further benefit issetting time, foams of the present subject matter set to a rigidity tostabilize an injured limb or extremity quickly. Foams of the presentsubject matter also cure to sufficient dryness and many embodiments aretack-free and at full strength in less than 5 minutes and are tack-freeand at sufficient rigidity and strength, making it advantageous inemergencies, military combat, and pediatric splinting. In oneembodiment, the foam is sufficiently tack-free and at full strength inless than 60 seconds.

In some embodiments, the foam sets as an open-cell foam. The term “opencell” as used herein refers to a foam wherein the majority of adjoiningcells are in open communication with each other, such thatinterconnected cells form spaces, chambers, and channels larger thanindividual foam cells. In some embodiments, open cell foam structureforms during the setting process where individual foam cells at leastpartially open their wall structure with adjoining cells and then set asa rigid foam. In some embodiments, use of an open cell foamadvantageously provides sufficient rigid support of the limb orextremity while simultaneously providing improved airflow to the skinwhich maximizes comfort and helps to decrease sweating, trapping ofcontaminants against the skin, and formation of sores, problems commonin traditional casts and wraps.

Foams of the present subject matter may include any synthetic-based ornatural-based foam formulation that can provide sufficient rigidity andalso optionally provide one or more of the uses or features disclosedherein. One embodiment of the present subject matter includes applying afoam that provides quick and effective immobilization of fractures.Non-limiting examples of foam formulations that may be useful for thepresent subject matter, having one or more of the features describedherein, include polyurethane foams and soy-based foams. The term“polyurethane foam” as used herein refers to a foam of the presentsubject matter obtained from a polyurethane that is the reaction productbetween a polyisocyanate and at least one polymer polyol. Thepolyisocyanates and polyols of polyurethane foams of the present subjectmatter may be derived from synthetic sources and/or natural sources,such as purified and/or synthesized from petroleum or agriculturalproducts (such as soy). In one embodiment, the polyurethane foam of thepresent subject matter may be based largely on soy beans, such asAmerican-grown soy bean extract, improving safety and environmentalconcerns. In one embodiment, polyurethane foams are formulated as atwo-component foam.

The term “two-component foam” as used herein refers to a foam that isproduced from the combination of two precursor compositions which mustbe combined in order to activate the foaming process. A two-componentpolyurethane foam composition is one non-limiting example of thetwo-component foam compositions of the present subject matter. In oneembodiment, a two-component foam provides one component in onepressurized container, typically the “A” container (i.e., polymericisocyanate, fluorocarbons, etc.) while a resin is supplied in a secondpressurized container, typically the “B” container (i.e., polyols,epoxy, polyester, latex, catalyst, flame retardants, etc.)

Spray polyurethane foam (SPF) is a product that is commonly used inbuilding and manufacturing as semi-rigid foam insulation. In someembodiments, SPF formulation comprises a two-component quick-cure foamformulation. In one combination, the SPF comprises the two components ofisocyanates and a polyols sprayed as a liquid on a surface and withinseconds expands and dries rigid or semi-rigid depending upon theformulation selected. In one embodiment, the SPF formulation is acommercially available polyurethane two-component quick-setting foamknown by the trade name FROTH-PAK, in package size named FROTH-PAK-12for 12 board feet of foam, and is manufactured by Dow Chemical (Midland,Mich.). Other package sizes of FROTH-PAK foam are commercially availablefor differing uses and often with different nozzles depending upon theapplication, and are useful as a foam of the present subject matter.FROTH-PAK-12 foam sets to sufficient rigidity with no-tackiness in lessthan 60 seconds, and in less than about 30 seconds. The commerciallyavailable series of FROTH-PAK foams generally provide a foam densityranging from about 1.7 to about 3.4 pounds per cubic foot. FROTH-PAK-12provides a foam density ranging from about 1.7 pounds per cubic foot to1.9 pounds per cubic foot.

It is noted that the FROTH-PAK series of foams provides a foam that setsto sufficient rigidity in less than 60 seconds, and does not produce anamount of heat release that is painful or uncomfortable on the skin ofthe human or animal. Commercially available FROTH-PAK-12 is so-namedbecause it provides 12 board feet of foam. In one embodiment, theFROTH-PAK foam is formulated in a two-component can to provide a volumeof foam that differs from the volume of foam that is currentlycommercially available. For example, FROTH-PAK foam may be formulated ina two-component can to provide 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 boardfeet of foam.

In one embodiment, the SPF polyol component formulation comprises: (1)Polyols Mixture 30-60%; (2) Diethylene Glycol CAS #111-46-6 1-5%; (3)Triethyl Phosphate CAS #78-40-0 1-5%; (4) Flame Retardants Mixture5-10%; (5) 1,1,1,3,3-Pentafluoropropane CAS #460-73-1 7-13%; and (6)1,1,1,2-Tetraflluoroethane CAS #811-97-2 10-30%. Data from FROTH-PAKPolyol component blend, MSDS (Rev. Mar. 10, 2006), incorporated hereinby reference in its entirety.

In one embodiment, the SPF isocyanate component formulation comprises:(1) Methylenediphenyl diisocyanate, homopolymer, about 40.0-60.0%, CAS#39310-05-9, EC# Polymer; (2) 4,4′-Methylenediphenyl diisocyanatediphenylmethane-4,4′-diisocyanate (MDI), about 40.0-60.0%, ClassifiedXn: R20, Xi: R36/37/38, R42/43, CAS #101-68-8 202-966-0; and (3)1,1,1,2-Tetrafluoroethane, about 5.0-10.0%, CAS #811-97-2, EC#212-377-0. Data from. FROTH-PAK Isocyanate component, MSDS (Rev. Oct.7, 2006), incorporated herein by reference in its entirety.

In one embodiment, the FROTH-PAK spray foam formulation can provide thefollowing features in the final foam product: Tack-free Time, <60seconds; Tensile Strength, ASTM D1623, psi (kPa), parallel about 40.1(276.4); Shear Strength, ASTM C273, psi (kPa), parallel about 23.9(164.8); Flexural Strength, ASTM C203, psi (kPa), min. about 23 (158.6);Compressive Strength, ASTM D1621, psi (kPa), min. about 22 (151.7);Apparent Core Density, ASTM D1622, lb/ft3 (kg/m3) about 1.70 (27.2);Water Absorption, ASTM D2842, % by volume, max. about 2.5; Water VaporPermeance, ASTM E96, perm (ng/Pa·s·m2), max. about 3.0 (4.38).

The load capacity of some two-component polyurethane foams, includingFROTH-PAK foams, may be changed by changing the amount or type ofblowing agent. That is, changing the amount and/or type of blowing agentcan vary foam density to achieve different compressive strengths.FORTH-PAK foams generally comprise a hydrofluorocarbon in the blowingagent composition. Foamable compositions may also be optionally premixedwith water in some embodiments. Water can be optionally included in theblowing agent composition of SPF's of the present subject matter.Generally, decreasing the amount of water used in the SPF blowing agentresults in foams having increased rigidity, and increased elasticmodulus. The expansion of the foam is also able to be adjusted thusallowing even thinner equally strong casts to be applied. The nozzleshape also determines the physical features of the sprayed foam in someembodiments. In one embodiment, a fan-spray shaped nozzle is used toprovide fast delivery and coverage of an injured limb or extremity. Themanipulation of load capacity of a foam may result in foams suitable fordifferent uses. For example, a foam can be made hard enough to actuallyadd structural strength to buildings or soft enough to insulate flexiblehoses. In one embodiment for larger adults a more dense formula could beused as compared to an embodiment for a smaller pediatric patient whichmight be less dense. In addition to density, the strength of a rigidpolyurethane foam may also be designed by selecting factors such ascatalyst, surfactant, type of mixing, and the type and proportions ofthe foaming system: base polyol and isocyanate. Also, besides itsstrength, polyurethane foam that has set is also impervious to water andresists absorption of other chemicals, an advantage for preserving thedurability and comfort of casts and splints.

The term “applied” as used herein refers to placing the foamablecomposition or foam on the intended site of use, such as, for example,on an injured limb or extremity, on an injured back, etc. In someembodiments, the foamable composition is activated to begin theformation of foam and then the foamable composition and/or foam isapplied to the site of intended use. In one embodiment, a two-componentfoamable composition is mixed to initiate the formation of foam and thenthe activated foamable composition is manually applied to the site ofuse. In another embodiment, a two-component foamable composition ismixed to initiate the formation of foam and then the activated foamablecomposition is applied by spraying the composition on the site of use.Any suitable propellant may be used to spray the foam formulation,non-limiting examples include physical volumetric pressure and chemicalpropellants, such a hydrocarbons and fluorohydrocarbons. In a furtherembodiment, a foam of the present subject matter is formulated as aspray foam composition premixed with one or more fluorohydrocarbonpropellants. In one embodiment of a two-component spray foamcomposition, the two components in separate containers are mixedtogether by channeling both components through a single applicatornozzle, wherein the two components mix in or near the nozzle to activatethe formation of foam and simultaneously the applicator nozzle is usedto apply the foam. In another embodiment, the two-components of a foamof the present subject matter are in two separate cans; the two separatecans are then further attached to one another or are enclosed in asingle can, container, or package; and the two-component cans areindividually connected to a single applicator or nozzle where thetwo-components may be mixed at the time of application at or near theapplicator or nozzle.

Generally, foam from a two-component SPF system is applied by mixingboth components to activate the foaming reaction, and then applying themixture to the selected location where foam is desired. In oneembodiment, the components are manually mixed and the foam is manuallyapplied. In another embodiment, the two components are mixed by sprayingthe components to form the foam where it is desired. The two componentsmay be mixed by simultaneously directing both components through asingle spray nozzle.

In one embodiment, the foam of the present subject matter is appliedquickly by spraying and without calculating the volume or quantity ofeach component.

The term “patient” as used herein refers to any human or animal that maybenefit from the use of any of the foam embodiments described herein. Insome embodiments, a patient is a human or animal that requires a cast orsplint to stabilize an injured limb or extremity, or requires a spineboard to immobilize the spine or head, or requires a compression bandageto stop or slow bleeding. Some non-limiting examples of a patientinclude adults, children, infants, domesticated animals, wild animals,pets, zoo animals, farm animals, dogs, cats, birds, horses, cattle,primates, and reptiles. The term “skin” as used herein refers to thekeratinized epidermis, mucosal epithelia, and epidermis coveredpartially or totally by hair or fur of a human or animal.

The term “injured limb or extremity” as used herein refers to a bodypart that is injured and that may require immobilization to minimizepain or discomfort of the injury, and/or to promote healing of theinjury, and/or to promote effective therapy for the injury. Non-limitingexamples of limbs or extremities include arms, shoulders, elbows,wrists, hands, fingers, legs, hips, knees, ankles, toes, neck, and back.Non-limiting examples of injuries include broken bones, damaged tissue,stretched or torn ligaments and tendons, surgical trauma, and surgicalreconstruction. In one embodiment, the foams of the present subjectmatter are useful for preparing post-surgical splints/casts for anyorthopedic-related surgery, including, for example, an open reductioninternal fixation (ORIF) procedure. The term “open wound” as used hereinrefers to an injury characterized by trauma to the skin involving anopening or cut in the skin.

The term “therapeutic agent” as used herein refers to an agent thatpromotes, induces, increases, or accelerates wound or injury healing orinitiates, accelerates or improves tissue growth, decreases or preventsgrowth undesirable bacteria or fungi, or reduces or eliminates thesensation of pain in the patient. Suitable therapeutic agents include,but are not limited to, antibiotic agents, hemostatic agents, andanesthetic agents. In one embodiment, the therapeutic agent is added tothe foam formulation before the foam is formed. In other embodiments,the therapeutic agent is applied directly to a wound on the animal orpatient before the foam is applied. In another embodiment, at least onetherapeutic agent may be provided in a kit for oral- orinjectable-administration to the patient. In one embodiment, thetherapeutic agent is a dry and/or granular formulation. In general,biomedical studies have shown that the sooner a wound is treated withantibiotics then the infection rate decreases. In one embodiment, theantibiotic gentamycin, tobramycin, vancomycin, or a combination thereofis added to the foamable composition before it is applied, and bothantibiotics have been shown to remain stable after being exposed to amoderate exothermic environment, such as the mild to moderate exothermicenvironment that may be generated by the foams of the present subjectmatter.

Non-limiting examples of antibiotic agents include chemical agents;Aminoglycosides; Ansamycins; Carbacephems; Carbapenems; Cephalosporins;Glycopeptides; Lincosamides; Macrolides; Monobactams; Nitrofurans;Penicillins; Polypeptides; Quinolones; Sulfonamides; Tetracyclines;Anti-mycobacterials; and other Antibiotics. Non-limiting examples ofchemical agents include iodine, peroxide, and mercurochrome.Non-limiting examples of Aminoglycosides include Amikacin, Gentamicin,Kanamycin, Neomycin, Netilmicin, Tobramycin, and Paromomycin.Non-limiting examples of Ansamycins include Geldanamycin and Herbimycin.Non-limiting examples of Carbacephems include Loracarbef. Non-limitingexamples of Carbapenems include Ertapenem, Doripenem,Imipenem/Cilastatin, and Meropenem. Non-limiting examples ofCephalosporins include Cefadroxil, Cefazolin, Cefalotin, Cefalexin,Cefaclor, Cefamandole, Cefoxitin, Cefprozil, Cefuroxime, Cefixime,Cefdinir, Cefditoren, Cefoperazone, Cefotaxime, Cefpodoxime,Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Cefepime, andCeftobiprole. Non-limiting examples of Glycopeptides includeTeicoplanin, Vancomycin, and Telavancin. Non-limiting examples ofLincosamides include Clindamycin and Lincomycin. Non-limiting examplesof Macrolides include Azithromycin, Clarithromycin, Dirithromycin,Erythromycin, Roxithromycin, Troleandomycin, Telithromycin, andSpectinomycin. Non-limiting examples of Monobactams include Aztreonam.Non-limiting examples of Nitrofurans include Furazolidone andNitrofurantoin. Non-limiting examples of Penicillins includeAmoxicillin, Ampicillin, Azlocillin, Carbenicillin, Cloxacillin,Dicloxacillin, Flucloxacillin, Mezlocillin, Methicillin, Nafcillin,Oxacillin, Penicillin G, Penicillin V, Piperacillin, Temocillin, andTicarcillin. Polypeptides include Bacitracin, Colistin, and Polymyxin B.Non-limiting examples of Quinolones include Ciprofloxacin, Enoxacin,Gatifloxacin, Levofloxacin, Lomefloxacin, Moxifloxacin, Nalidixic acid,Norfloxacin, Ofloxacin, Trovafloxacin, Grepafloxacin, Sparfloxacin, andTemafloxacin. Non-limiting examples of Sulfonamides include Mafenide,Sulfonamidochrysoidine, Sulfacetamide, Sulfadiazine, Silversulfadiazine, Sulfamethizole, Sulfamethoxazole, Sulfanilimide,Sulfasalazine, Sulfisoxazole, Trimethoprim, andTrimethoprim-Sulfamethoxazole. Non-limiting examples of Tetracyclinesinclude Demeclocycline, Doxycycline, Minocycline, Oxytetracycline, andTetracycline. Non-limiting examples of Anti-mycobacterials includeClofazimine, Dapsone, Capreomycin, Cycloserine, Ethambutol, Ethionamide,Isoniazid, Pyrazinamide, Rifampicin, Rifabutin, Rifapentine, andStreptomycin. Non-limiting examples of other Antibiotics includeArsphenamine, Chloramphenicol, Fosfomycin, Fusidic acid, Linezolid,Metronidazole, Mupirocin, Platensimycin, Quinupristin/Dalfopristin,Rifaximin, Thiamphenicol, and Tinidazole).

One non-limiting example of a hemostatic agent is QUIK-CLOT.Non-limiting examples of anesthetic agents include lidocaine,prilocaine, bupivicaine, levobupivacaine, ropivacaine, mepivacaine,dibucaine, procaine, amethocaine, and combinations thereof.

The term “medical dressing for open wounds” as used herein refers to amedical dressing for covering and protecting open wounds fromcontamination and/or environmental elements. In one embodiment, themedical dressing for open wounds is breathable and transparent, such as,for example, TEGADERM. The term “open wound” as used herein refers to anarea of skin that has been opened by injury or trauma, such as, forexample, bullet and shrapnel wounds, cuts, bums, sutured wounds, severeskin disease, severe tissue disease, and surgical trauma. In one kitembodiment, a medical dressing, such as TEGADERM, is provided in apackage accompanying the can, such as, attached to the can or under acap on the can.

The term “cleaning irrigant” as used herein refers to a physiologicallycompatible liquid useful for irrigating and cleaning a wound area toremove foreign debris. Non-limiting examples of cleaning irrigantsinclude saline, water, blood plasma, liquids containing one or more anantibiotic compounds (such as gentamycin, vancomycin, tobramycin), andcombinations thereof.

The term “dye or coloring agent” as used herein refers to a synthetic ornatural chemical or chemical composition that may be added to thefoamable formulation to cause the final rigid foam to have a selectedcolor. Non-limiting examples of colors that the dye or coloring agentmay provide include, for example, green, sand, black, blue, pink, red,orange, yellow, and metallic colors. The color of the foam may bechanged for a variety of reasons including, for example, providingcamouflage for combat situations; providing identification for emergencysituations; providing event information to assist clinical diagnosis;and providing color preferences for patients, including children andparents of pediatric patients.

In one embodiment, a cast for stabilizing an injured limb or extremityof a human or animal is provided comprising a foam applied directly tothe human or animal without requiring a prewrap and allowed to set intoa sufficiently cast. In one embodiment, a cast is provided comprising afoam sprayed directly onto the skin of the limb or extremity and allowedto set. In another embodiment, a cast is provided comprising a foamsprayed directly onto the skin and the foam does not produce an amountof heat release that is painful or uncomfortable on the skin of thehuman or animal. In yet another embodiment, the foam is a polyurethanefoam, such as, for example, a two-component quick-cure polyurethanefoam. Also, for example, the polyurethane foam of the present subjectmatter may be a polyurethane foam that is not activated by water, and/ora polyurethane foam that does not produce an amount of heat release uponactivation that is painful or uncomfortable on the skin of the human oranimal. In a particular embodiment, the foam is FROTH-PAK foam, atwo-component quick-cure polyurethane foam, commercially available andproduced by Dow Chemical Company. In another embodiment, the foam is asoy-based foam. In several embodiments, the foam is an open-cell foam.In some embodiment, foams of the present subject matter set tosufficient rigidity in less than 60 seconds. In further embodiments,foams of the present subject matter set to sufficient rigidity in lessthan 30 seconds.

The present subject matter also provides a method for stabilizing aninjured limb or extremity of a human or animal comprising spraying afoam of the present subject matter on the injured limb or extremity of ahuman or animal, wherein the foam does not produce an amount of heatrelease that is painful or uncomfortable to the human or animal; andallowing the foam to harden into a cast having sufficient rigidity inless than 60 seconds.

The rigid foam cast or splint may be readily removed by conventionalmethods, including cutting the cast from the body using a knife, saw,laser, heating element, chemical degradation, or other method. In oneembodiment, if the foam is applied directly to the skin, a thin layer oflubricating or insulating composition or emollient may be optionallytopically applied to the skin before the foam is applied to increase theease of removing the cast or splint from the injured limb or extremity.

In one embodiment, the cast is prepared in a combat or emergencysituation at or near the geographic location where the injury occurred.In some embodiments, the injured limb or extremity comprises brokenbone, damaged or missing tissue, cuts, sutures, bullet or shrapnelwounds, or other open wounds. In another embodiment, the foam cast alsoslows or stops bleeding from a cut or wound on the injured limb orextremity. Foams of the present subject matter may further comprise anactive therapeutic agent, such as, for example, an antibiotic orhemostatic agent. Foams of the present subject matter may furthercomprise a dye or coloring agent, such as, for example, a dye to colorthe cast in a combat camouflage color, such as green, sand, black, etc.In another embodiment, a method of preparing a cast further comprisesirrigating a wound area on the injured limb or extremity with a salinesolution to remove contaminants or foreign debris before applying thefoam. In yet another embodiment, a method of preparing a cast furthercomprises applying at least one antibiotic agent to a wound area on theinjured limb or extremity before applying the foam, such as, forexample, at least one antibiotic agent is selected from the groupconsisting of Tobramycin, Vancomycin, Gentamycin, Cefazolin, or acombination thereof. In still another embodiment, a method of preparinga cast further comprises applying at least one anticoagulant to a woundarea on the injured limb or extremity before applying the foam. In afurther embodiment, a method of preparing a cast further comprisesapplying at least one medical dressing for open wounds to a wound areaon the injured limb or extremity before applying the foam.

In a further embodiment, a method of preparing a cast further comprisesobtaining a walled-form with walls enclosing an empty interior space andhaving one open end and the other end is either transparent or open andfitted with an optional detachable cover, wherein the width of thewalled-form is less than the width of the injured limb or extremity;placing the open end of the walled-form against the limb or extremityand around a selected wound area on the injured limb or extremity beforedispensing the foam on the injured limb or extremity; dispensing thefoam around the outside of the walled-form and on the injured limb orextremity so that the walled-form prevents foam from covering the woundarea; and forming an observation area to observe the wound inside thewalled-form after the foam is dispensed to stabilize the injured limb orextremity. In one embodiment, the walled-form also functions as a cap orend piece that is attached to a foam dispenser, such as a spray can offoam.

In one embodiment, the subject matter of the present subject matter alsoprovides a one-step method is provided for stabilizing an injured limbor extremity of a human or animal in an emergency or combat situationcomprising dispensing a foam directly on the skin or clothing of theinjured limb or extremity of the human or animal, wherein the foam doesnot produce an amount of heat release that is painful or uncomfortableon the skin of the human or animal, wherein the foam hardens into a casthaving sufficient rigidity in less than 60 seconds, such as, forexample, in less than 30 seconds.

In another embodiment, the subject matter of the present subject matteralso provides a kit for stabilizing an injured limb or extremity of ahuman or animal in an emergency or combat situation comprising adispenser comprising a foamable composition of the present subjectmatter, wherein the foam sets to sufficient rigidity in less than 60seconds after dispensing the foam on the injured limb or extremity. Inone embodiment, the foam in the kit does not produce an amount of heatrelease that is painful or uncomfortable on the skin of the human oranimal. In a further embodiment, the kit further comprises one or morecomponents to be applied to the injured limb or extremity before thefoam is dispensed on the injured limb or extremity selected from thegroup consisting of at least one package comprising a cleaning irrigant;at least one package comprising a hemostatic agent; at least one packagecomprising an antibiotic agent; at least one package comprising ananesthetic agent; at least one package comprising a medical dressing foropen wounds; and combinations thereof. In one embodiment, the kitfurther comprises one or more components to be applied to the injuredlimb or extremity before the foam is dispensed on the injured limb orextremity selected from the group consisting of at least one package ordispenser comprising saline irrigant; at least one package comprisingQUIK-CLOT hemostatic agent; at least one package comprising anantibiotic agent selected from the group consisting of Tobramycin,Vancomycin, Cefazolin, or a combination thereof; at least one packagecomprising TEGADERM wound dressing for dressing open wounds; andcombinations thereof. In one embodiment, the kit comprises a firstdispenser comprising a foamable composition of the present subjectmatter; a second dispenser comprising a cleaning irrigant; at least onepackage comprising a hemostatic agent; at least one package comprisingan antibiotic agent; at least one package comprising a medical dressingfor open wounds; and an open-walled form for creating an observationarea in the cast.

In one embodiment, the first dispenser and second dispenser are bothintegrated into a single can with a first nozzle or dispenser at one endfor spraying the foam from a first chamber(s) of the can, and a secondnozzle or dispenser at the other end for applying a cleaning irrigantcontained in another chamber of the can. In another embodiment, the kitfurther comprises a timing device to be affixed to the patient or castwhich may be activated at the time the cast is applied to provideinformation to the medical care provider of time of injury. In a furtherembodiment, each dispenser end, caps on the ends of the dispenser,and/or kit component are color-coded, pattern-coded, number-coded,and/or word-coded to provide one or more indicators of which end and/orcomponent should be opened and applied first, and which should be openedand applied second, etc. In a yet another embodiment, writteninstructions for using the kit and/or one or more of its components areincluded in the kit, such as, for example, affixed to the outside of thedispenser, written on individual component packages, and/or as one ormore separate documents. In many embodiments, the kit is lightweight,portable, and easily stored and transported by emergency personnel, inmilitary combat packs, in private and public vehicles andtransportation, and in first aid kits. The widespread availability anduse of a kit of the present subject matter in society can significantlyimprove quality and speed of emergency and orthopedic healthcare ofstabilizing and treating injuries and wounds while minimizing the painand discomfort of the patient.

In yet another embodiment, the kit further comprises an walled-form(such as, for example, a detachable cap or end piece attached to thedispenser in the kit) having one open end and the other end is eithertransparent or open and fitted with a detachable cover, the cap or endpiece can be placed around a selected wound area on the injured limb orextremity to prevent foam from covering the wound area so that it canremain open to observation after the foam is dispensed to stabilize theinjured limb or extremity. The walled-form has sufficient structuralintegrity to maintain an open observation area in the cast on theinjured limb or extremity, the observation area in the cast being freeof foam after the foam is applied to the limb or extremity. In oneembodiment, an open-ended walled form is placed over the wound areabefore the rigid foam cast is sprayed on the injured extremity. Thewalled-form may be made of any material having the sufficient structuralintegrity. Nonlimiting examples walled-form materials include plastics,polymers, rubber, metals, artificial fibers (such as fiberglass),natural fibers (such a paper or cardboard), recycled materials, andother materials. open-ended walled-form with an optional detachablecover. The present subject matter also provides a cast, and a method ofmaking a cast, having an open observation area in the cast on theinjured limb or extremity for observing a wound on the limb orextremity. The observation area in the cast being free of foam after thefoam is applied to the limb or extremity. In some embodiments, a casthaving an observation area over a wound advantageously providesstabilization of an injured limb or extremity while simultaneouslyallowing the wound to remain open to observation or access so thatmedical care personnel can assess and/or treat the wound withoutremoving the stabilizing cast.

In a further embodiment, the subject matter of the present subjectmatter also provides a spine board for stabilizing an injured patientcomprising a foam of the present subject matter applied onto the back ofthe patient and allowed to set while the foam on the patient's back iscontacting a board or flat surface. In one embodiment, a foam of thepresent subject matter is sprayed directly on the skin or on theclothing of the patient, or on the board or flat surface, and the foamdoes not produce an amount of heat release that is painful oruncomfortable for the patient. FIG. 4(A&B) shows one example of thepresent spine board and a method for in situ manufacture and placementof a spine board for stabilizing an injured patient (401) comprisingrolling the patient to at least partially raise the back (402) of thepatient (401); placing a board or flat surface (403) under the back ofthe patient; dispensing a foam of the present subject matter (404) onthe clothed or unclothed back (402) of the patient, on the surface ofthe board or flat surface (403), or a combination thereof; rolling theback (402) of the patient onto the board or flat surface (403) beforethe foam has set (404), wherein the foam does not produce an amount ofheat release that is painful or uncomfortable to the patient; andallowing the foam to harden (405) into a spine board having sufficientrigidity in less than 60 seconds. In some embodiments, the spine boardalso comprises at least one restraint or strap for keeping the patientsecurely attached to the spine board. In another embodiment, the boardor flat surface used to make the spine board has one or more holes ordepressions, an uneven surface, a textured surface, or a combinationthereof. The very nature of the foam also creates a very strongflotation device that could be applied to the spine as a buoyant spineboard for water extracations.

In one embodiment, the subject matter of the present subject matter alsoprovides a method for in situ preparation and application of acompression bandage on an injured patient in an emergency or combatsituation comprising applying a foam of the present subject matter onthe injured patient and covering the wound requiring a compressionbandage, wherein the foam does not produce an amount of heat releasethat is painful or uncomfortable on the skin of the human or animal; andallowing the foam to harden in less than 60 seconds to a rigiditysufficient to stop or slow the flow of blood. In some embodiments, foamsof the present subject matter, including SPF, sprayed circumferentiallyaround an entire extremity can slow or stop bleeding from an open wounddue in-part to the fact that the foam does not absorb fluids, andthereby keeps bleeding compressed at the site of the open wound.Accordingly, the present subject matter may be useful for preparingcompression bandages.

The subject matter of the present subject matter also provides a methodfor in situ preparation of a compression pad for minimizing theoccurrence of pressure sores in the feet of diabetic humans. Pressuresores may occur in variety of circumstances. Nonlimiting examplesinclude bed-ridden patients, surgical patients, diabetic, feet,repetitive work motions, bony protuberances, carrying large packs orburdens, saddle sores, and pack sores. In situ preparation andapplication of a foam of the present subject matter on the area on thebody to be protected followed by immediately allowing the pressure to beapplied to the body, wherein the foam takes on the precise contours ofthe body, and thereby creates an even stress load distribution whichminimizes the likelihood of pressure sores developing on the body areahaving the foam padding of the present subject matter. In oneembodiment, the patient is suffering from bed sores, and the foam isapplied around the area of the bed sore, but not directly on the sores,and the patient is lowered to the mattress to position the body on thein situ made foam padding. The foam padding may be optionally re-used ifit can be precisely placed in the same body position. In anotherembodiment, a patient's body is positioned for surgery, and then thebody location prone to sores is slightly lifted and SPF is sprayed ontothe body location and the patient carefully lowered to the surgical matso that the foam creates a pad that easily and naturally follows thecontours of the body, and thereby creates an even stress loaddistribution which minimizes the likelihood of pressure sores developingon the padded body location. In another embodiment, the skin of a horse,or beast of burden, to be located under a saddle or pack is sprayed witha layer of SPF and the saddle of pack is immediately placed over thefoam and the saddle or pack is compressed to create a pad that followsthe contours of the body.

The following are non-limiting examples of the subject matter describedherein.

EXAMPLE 1

FROTH-PAK-12 (Dow Chemical Corporation) was obtained from a constructionsupply store. The product contained one pressurized can of isocyanateformulation and another pressurized can of polyol blends. Both cans wereconnected by tubes to a single spray handle with a single nozzle. Bothcans were sprayed simultaneously through the single nozzle, therebymixing the two components while spraying the mixture as a fine spray.

The extremity was first positioned so that a single continuousapplication of spray could be applied circumferentially to the entireextremity as needed. One single coat of the FROTH-PAK was then sprayedcircumferentially on the extremity. FIG. 1A shows a photograph of anexample of the rigid foam cast of FROTH-PAK sprayed directly on the skinof the arm, wrist, and hand. FIG. 1B is a photograph of the cast in FIG.1A after the arm was removed from the cast. An open-cell structure canbe seen in FIG. 1B.

EXAMPLE 2

FIG. 2(A&B) schematically shows one example of a kit of the presentsubject matter comprising a dispenser (201) comprising a foamablecomposition of the present subject matter. A cap (202) may cover thefoam dispenser nozzle. In this example, packages of antibiotic powder(204), granular hemostatic agent (205), and a medical dressing (206) fordressing open wounds are provided in the kit, such as being placed underone or more end caps (202, 203), or affixed to the outside of thedispenser (201). A first cap (202) covers a spray foam nozzle (208), anda second cap (203) covers a nozzle or applicator (209) for dispensing aliquid irrigant, such as saline. Also in this example, the seconddetachable cap (203) is a walled-form having one open end and the otherend of the cap is open and fitted with a detachable cover (207). Thiswalled-form cap (203) can be placed around a selected wound area on theinjured limb or extremity to prevent foam from covering the wound areaso that it can remain open to observation after the foam is dispensed tostabilize the injured limb or extremity. In one embodiment, thedetachable cover (207) may be partially covered with foam eitheraccidentally or deliberately to keep the cover in place, and the foam onthe cover may then be easily removed later by the medical care providerto access the observation area formed by the walled-form.

EXAMPLE 3

FIGS. 3A (top view) and 3B (side view) schematically show an example ofa rigid foam cast (301) of the present subject matter on an injuredextremity (302) having an open wound (303) and the cast comprising anopen-ended walled-form (304) with an optional detachable cover (305).The walled form (304) and cover (305) are placed over the wound areabefore the rigid foam cast is sprayed on the injured extremity so thatthe wound can remain open to observation or access after the foam castis applied to stabilize the injured limb or extremity. FIG. 3A, showsremoval of the detachable lid (305) from the walled-form (304) so thatthe wound (303) can be accessed for observation and/or treatment.

EXAMPLE 4

FIG. 4 schematically shows an example of a spine board of the presentsubject matter and a method of preparing and placing the spine board onthe patient. A patient (401) requiring a spine board to be applied tothe patient's back (402) is rolled on their side and a board or flatsurface (403) is placed where the back (402) will be placed. The foam(404) of the present subject matter is then applied to the patient'sback (402) and/or the board or flat surface (403) and the patient isimmediately rolled back onto the board or flat surface (403) before thefoam sets. The foam is then allowed to set to sufficient rigidity (405).The patient and spine board may then be moved. The spine board mayoptionally further comprise one or more restraints (such as straps) forimmobilizing the patient and/or securing the patient to the spine board.

EXAMPLE 5

The Orthopedic Battle System (OBS) Kit: The base structure is a simplespray can and cap similar to any spray can. The can has two caps (blueand green) one at each end of the can. The can has two nozzles, oneunder each cap at each end. Under the blue cap is a nozzle that sprayssimple normal saline irrigation. Under the green cap is a nozzle thatsprays the foam. The can contains a two-component SPF, wherein eachcomponent is stored in its own separate container in the can. The twocomponents are mixed while spraying both components simultaneously thruthe nozzle under the green cap. Under the blue cap are two packets thesize and shape of table sugar, each will contain a different powderedantibiotic, such as, for example, Tobramycin and Vancomycin. The greencap will have a re-sealable lid similar to a TUPPERWARE lid. Under thislid will be two packets of QUICK-CLOT, a granular chemical hemostaticagent. Under a wrapper attached to the body of the can is an impervioustransparent self adherent medical dressing wound cover (TEGADERM) foroptionally covering larger open wounds if they are present. A simple tocomplex wound may be identified, the wound is first irrigated to removecontaminants, then antibiotics are sprinkled into the wound, if bleedingis an issue then QUIK-CLOT is applied to the bleeding wound. The greencap is placed over the open wound and spray foam is applied around thelid and circumferentially around the extremity. Excess foam on the lidcan later be removed to access the observation area. In less than 1minute, the wound can be irrigated, antibiotics applied, bleedingcontrolled, and the fracture stabilized in a rigid foam splint all withone simple compact can kit.

EXAMPLE 6

Emergency workers respond to an accident and a person is found to have abroken arm with a bone sticking out of the skin (compound fracture). Thearm is evaluated for circulation and neurologic injury. The open woundis optionally: irrigated with saline, treated with antibiotics, treatedwith a hemostatic agent to stop excess bleeding, and/or covered with amedical dressing. The arm and wound is then sprayed directly with atwo-component SPF in a circumferential manner, the foam expands, driesand hardens within seconds. The person can then be transported to ahospital or medical clinic without further stabilizing the injured arm.The spray foam is in a one-time dose can containing both of thetwo-components in separate chambers. The can similar in size to a smallcan of hairspray that is easy to store and transport. Both componentsare automatically mixed at the time of application when sprayed from asingle nozzle connected to both chambers.

EXAMPLE 7

A pediatric patient is found to have a fractured leg requiring animmobilizing cast to allow proper bone healing. The leg is evaluated forcirculation and neurologic injury, fracture reduction, and molding andthen the leg is then sprayed directly with a two-component SPF in acircumferential manner, the foam expands, dries and hardens withinseconds. In this example, the pediatric patient does not require asedative or general anesthesia to permit application of the cast, whichcontrasts with other prior art casting methods which require sedation inorder to have the pediatric patient lay motionless for a lengthy castingprocedure. The foam cast has a high strength to weight ratio and is muchlighter than conventional casts, permitting near normal motion. A dyecolor is added to the cast to enhance patient acceptance of the cast.The foam cast does not absorb urine and fecal matter as does the castpadding in prior art casts and methods; this reduces the number of castchanges and skin break down issues. Many pediatric fractures do notrequire manipulation just stabilization, therefore the quick-settingfoams of the present subject matter can be quickly and easily applied.

EXAMPLE 8

A patient with diabetes is found to have a fractured ankle requiring acast to allow proper bone healing. However, diabetics have bloodcirculatory problems and have many problems in traditional casts due tothe frequent formation of pressure sores, especially in diabetic feet.The ankle is positioned and SPF is sprayed onto the ankle, foot, andlower leg so that the foam easily and naturally follows the contours ofthe lower leg directly, and thereby creates an even stress loaddistribution which minimizes the likelihood of pressure sores developingon the treated extremity, and thereby promotes healing of sores that arealready present.

EXAMPLE 9

A surgical patient is being prepared for orthopedic reconstruction andreplacement surgery, a lengthy surgical procedure requiring more than 2hours on the operating table in one position. Such lengthy surgeries,requiring the patient to be in one position, are known to createpressure sores in specific body locations and must be padded.Traditional pads often do not perfectly conform to the patient's bodyand thereby leave the patient prone to developing pressure sores. Thepatient's body is positioned for surgery, and then the body locationprone to sores is slightly lifted and SPF is sprayed onto the bodylocation and the patient carefully lowered to the surgical mat so thatthe foam creates a pad that easily and naturally follows the contours ofthe body, and thereby creates an even stress load distribution whichminimizes the likelihood of pressure sores developing on the padded bodylocation.

It will be understood that many additional changes in the details,materials, steps and arrangement of parts, which have been hereindescribed and illustrated to explain the nature of the present subjectmatter, may be made by those skilled in the art within the principle andscope of the present subject matter as expressed in the appended claims.

What is claimed:
 1. A method for stabilizing an injured limb orextremity of a human or animal comprising: providing a two-componentquick-cure spray polyurethane foam; spraying the foam directly onto theskin of the injured limb or extremity of a human or animal; using thefoam, producing an amount of heat release that is not painful oruncomfortable on the skin of the human or animal; and allowing the foamto harden into a cast having sufficient rigidity in less than 60seconds.
 2. The method according to claim 1, wherein the foam isFROTH-PAK foam.
 3. The method according to claim 1, wherein the foam isa quick-cure soy-based foam.
 4. The method according to claim 1, whereinthe foam is an open-cell foam.
 5. The method according to claim 1,further comprising stabilizing the injured limb or extremity at alocation at or near where the injury occurred.
 6. The method accordingto claim 1, further comprising using the cast to inhibit or preventbleeding from a cut or wound on the injured limb or extremity.
 7. Themethod according to claim 1, wherein the foam further comprises anactive therapeutic agent.
 8. The method according to claim 1, whereinthe foam further comprises a dye or coloring agent.
 9. The methodaccording to claim 1, further comprising irrigating a wound area on theinjured limb or extremity with a saline solution to remove contaminantsor foreign debris before spraying the foam.
 10. The method according toclaim 1, further comprising applying at least one antibiotic agent to awound area on the injured limb or extremity before spraying the foam.11. The method according to claim 10, wherein the at least oneantibiotic agent is selected from the group consisting of Tobramycin,Vancomycin, or a combination thereof.
 12. The method according to claim1, further comprising applying at least one hemostatic agent to a woundarea on the injured limb or extremity before spraying the foam.
 13. Themethod according to claim 1, further comprising applying at least onemedical dressing for open wounds to a wound area on the injured limb orextremity before spraying the foam.
 14. The method according to claim 1,further comprising providing a form with solid walls surrounding anempty space, the form having one open end and another end that is eithertransparent or open and fitted with an optional detachable cover,wherein the width of the form is less than the width of the injured limbor extremity; placing the one open end of the form against the limb orextremity and around a selected wound area on the injured limb orextremity before spraying the foam on the injured limb or extremity;spraying the foam around the outside of the form and on the injured limbor extremity so that the form prevents the foam from covering the woundarea; and forming an observation area to observe the wound inside theform after the foam is sprayed to stabilize the injured limb orextremity.
 15. A one-step method for stabilizing an injured limb orextremity of a human or animal in an emergency or combat situationcomprising: spraying a two-component quick-cure spray polyurethane foamdirectly on the skin or clothing of the injured limb or extremity of thehuman or animal, wherein the foam does not produce an amount of heatrelease that is painful or uncomfortable on the skin of the human oranimal and wherein the foam hardens into a cast having sufficientrigidity in less than 60 seconds.